Dulaglutide
-3129.jpg) | |
| Clinical data | |
|---|---|
| Trade names | Trulicity, others[1] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a614047 |
| License data |
|
| Pregnancy category |
|
Subcutaneous | |
| Drug class | Incretin mimetics |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| UNII | |
| KEGG | |
| ChEMBL | |
| Chemical and physical data | |
| Formula | C2646H4044N704O836S18 |
| Molar mass | 59670.63 g·mol−1 |
Dulaglutide, sold under the brand name Trulicity among others,[6] is a medication used for the treatment of type 2 diabetes in combination with diet and exercise.[7][8] It is also approved in the United States for the reduction of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease or multiple cardiovascular risk factors.[9] It is a once-weekly injection.
The most common side effects are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.[6]
It is a
Medical uses
The compound is indicated for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control. Dulaglutide is not indicated in the treatment of subjects with type 1 diabetes or patients with diabetic ketoacidosis because these problems are the result of the islet cells being unable to produce insulin and one of the actions of dulaglutide is to stimulate functioning islet cells to produce more insulin. Dulaglutide can be used either stand-alone or in combination with other medicines for type 2 diabetes, in particular metformin, sulfonylureas, thiazolidinediones, and insulin taken concomitantly with meals.[14]
The medication's phase 3 clinical trial program demonstrated reductions in hemoglobin A1c of approximately 1% with the 0.75 mg and 1.5 mg doses of the medication, along with approximately 5 pounds of weight loss on average. The higher 3.0 mg and 4.5 mg doses that were approved in 2020 demonstrated hemoglobin A1c reductions closer to 1.5% and slightly more weight loss.[10]
A 2017 meta-analysis did not support the suggestion that treatment with GLP-1 agonists or DPP-4 inhibitors increased all-cause mortality in type 2 diabetics.[15]
Side effects
The most common side effects include gastrointestinal disorders, such as
Contraindications
The compound is contraindicated in subjects with hypersensitivity to the active ingredient or any of the product's components.[citation needed]
People with a personal or family history of medullary thyroid cancer (MTC) or affected by multiple endocrine neoplasia type 2 should not take dulaglutide, because it could increase the risk of these cancers.[20][6]
Mechanism of action
Dulaglutide binds to glucagon-like peptide 1 receptors, slowing gastric emptying and increasing insulin secretion by pancreatic Beta cells. Simultaneously the compound reduces the elevated glucagon secretion by inhibiting alpha cells of the pancreas, as glucagon is known to be inappropriately elevated in diabetic patients. GLP-1 is normally secreted by
History
The safety and effectiveness of dulaglutide were evaluated in six clinical trials in which 3,342 subjects with type 2 diabetes received dulaglutide. Subjects receiving dulaglutide had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).[6]
The U.S.
In 2020, the FDA approved two higher doses of the medication, 3.0 mg and 4.5 mg, based on results of the AWARD-11 trial demonstrating improved glucose lowering and weight benefits.[22]
References
- ^ "Dulaglutide international". Drugs.com. 3 January 2020. Retrieved 4 February 2020.
- ^ "Dulaglutide (Trulicity) Use During Pregnancy". Drugs.com. 15 July 2019. Retrieved 4 February 2020.
- FDA. Retrieved 22 October 2023.
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
- ^ a b c d e f g "FDA approves Trulicity to treat type 2 diabetes" (Press release). U.S. Food and Drug Administration (FDA). 18 September 2014. Archived from the original on 20 April 2016. Retrieved 4 February 2020.
This article incorporates text from this source, which is in the public domain.
- S2CID 73313508.
- ^ "Lilly's Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes" (Press release). Eli Lilly. 25 February 2014.
- ^ "Trulicity (dulaglutide) is the first and only type 2 diabetes medicine approved to reduce cardiovascular events in adults with and without established cardiovascular disease". Eli Lilly and Company (Press release). 21 February 2020. Retrieved 23 February 2020.
- ^ a b "Drug Approval Package: Trulicity (dulaglutide) NDA #125469". U.S. Food and Drug Administration (FDA). 27 October 2014. Retrieved 4 February 2020.
- ^ "Trulicity EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 23 February 2020.
- ^ "The Top 300 of 2021". ClinCalc. Retrieved 14 January 2024.
- ^ "Dulaglutide – Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
- PMID 25029955.
- PMID 28596247.
- PMID 24742660.
- PMID 24918645.
- S2CID 33922845.
- ^ a b "Risk Evaluation and Mitigation Strategy (REMS)". United States Food and Drug Administration. September 2014. Retrieved 24 March 2020.
- S2CID 6933973.
- PMID 24373234.
- PMID 33397768.
Further reading
- Scott LJ (February 2020). "Dulaglutide: A Review in Type 2 Diabetes". Drugs. 80 (2): 197–208. S2CID 210954338.
- Edwards KL, Minze MG (2015). "Dulaglutide: an evidence-based review of its potential in the treatment of type 2 diabetes". Core Evidence. 10: 11–21. PMID 25657615.
- Romera I, Cebrián-Cuenca A, Álvarez-Guisasola F, Gomez-Peralta F, Reviriego J (February 2019). "A Review of Practical Issues on the Use of Glucagon-Like Peptide-1 Receptor Agonists for the Management of Type 2 Diabetes". Diabetes Therapy. 10 (1): 5–19. PMID 30506340.
